Requirements

• Copy of all DSMB reports
• Copy of all audit reports

FAQs

Q: Does the IRB need a copy of DSMB reports?

Yes. Submit the most recent DSMB report to the IRB as soon as it becomes available.

Q: In addition to DSMB reports, should any other documentation be kept on file?

Yes. Keep and file any additional correspondence (e.g., e-mails, letters, meeting minutes) with the DSMB and its members.

Q: This study does not have a DSMB. Is any data and safety monitoring documentation required?

Yes. As of July 15, 2005, the Partners HRC requires all protocols to include a data and safety monitoring plan. Specifications are listed in the link below.

Useful Links

PHRC Data and Safety Monitoring Plans:

http://healthcare.partners.org/phsirb/datasafe.htm